Q4 2019 Earnings Call

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The speakers presentation, there will be a question and answer session.

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I'd now like the hand, the conference over to your speaker today.

Our balance sheet.

Chief Executive Officer.

You may begin.

Thank you.

Good afternoon Europe, good morning here in the U.S.

Thank you for joining us for our full year 2019 earnings call.

No we announced a full year in fourth quarter 2019 financial results and business update yesterday evening.

You can access the briskly and the earnings presentation on our Investor Relations page Oh part what sites Www every take docomo.

The older coal we are also our chief Medical officer.

I really and other rigs or chief financial and Chief operating officer.

As you can imagine that you have implemented strict rules to Mexico. It makes the money protect our employees and the company from the grown a virus outbreak, we're oaktree connected from different locations.

So I draw your attention to the slight too.

The disclaimer on slide two.

And here I underlined when one sentence that went to go the attention to the uncertainty around the covert 19 situation.

We are as you can imagine very closely monitoring the potentially but over the pandemic wouldn't particular focus on the timing and conduct our.

At this stage, we're able to produce a supply or every as they supposed to open the call fights, even in Italy and Spain.

And.

You will see we are maintaining the timelines we have guided before but we are obviously aware that this may be going increasingly challengers and.

We will provide more more detailed jewelry.

During the uptick.

So switching to slide three the agenda, our quarterly routine I will start with the business update focusing on the key highlights for.

Fourth quarter and you have today.

I think we'll then take over present the financial highlights for the full year production my team and summarize the major expected milestones for the year to come.

Then the tree of a school, they're off to be available to respond to your questions.

[music] no before starting the update I'm switching to slide four it's a quick reminder of the company.

No changes here, we still are and increasingly so at the leader in Red cell based therapeutic.

Focusing on cancer metabolism would late stage clinical programs and now we fully operational manufacturing sites, Georgia, One recently expanded.

India.

For treatment of European European patients and the second one now nobody established in Princeton Ford U.S.

The graph on the right hand.

The remainder of the phase two study in second line pancreatic cancer, where we showed 40% reduction in risk of Vetri to our knowledge the strongest results ever seen in Asia.

Large clinical trial in second line pancreatic cancer and the basis for our development in phase three.

The next slide slide five presents the overview of our clinical and preclinical pipeline also here no change already program lead product candidate area space.

Yes, burgeoning in red cells.

You know evaluated in three clinical trials now a pivotal phase three in second line pancreatic cancer drug with a one phase two in first line triple negative breast cancer Tribeca, two and a phase two in second line yellow acute lymphoblastic leukemia and decision I used the investigator sponsored trial led by.

No for the Nordic Society, pediatric hematology and oncology.

In order I see faced one in first time pancreatic is being prepared for launch in first half of next year.

I will provide brief update all four of these broke the trials in the coming flights.

And also on the preclinical pipeline afterwards.

So.

Moving to the main domain Toping topic, a one on slide six.

The phase three if they can find pancreatic cancer.

I'm very pleased and proud to say that we are.

Two thirds enrolled or at least that's the yen to February already we were two thirds enrolled.

In this trial, it's the trial with 500 opposed to 500 patients were enrolled.

At this stage, we continued to be on track for full enrollment in the third quarter.

That introduction, we are still able to fly to all the sites that being said we are very closely monitoring the potential impact of the coffee. Thank you defer to conduct and timing ought to study.

But at least today, we are continuing to do supply us.

Uh huh.

But.

We are now destroy listen going in 65.

Sites in 11 countries in Europe, and United States.

And if you wish we communicated in November already past two safety because in fact this moment in the beginning and then one 150 patients in November.

The next Securities you is expected in in the coming.

The good news flow item for the company. This year is reporting of the results of the interim analysis, it's an interim analysis for superiority Glenn score when towards OTI events will have secured.

This is also currently expected to occur in the third quarter. The with the same caveat as expressed before US we expect increasing difficulties for the monitors to be able to visits decides to.

Got to do that monitored the data.

Just a reminder, this interim analysis this stage superiority analysis.

Should we I don't know notice was utilities. So there are two possible outcomes or the trial continues to work its final analysis, which.

Good thing first half lets say mid 2021.

The second would be that the travel already can be stopped for superiority. If the primary endpoint. The primary survival endpoint is dismissed.

In that case that would allow to stop the study and started preparing for the filings both.

And with that.

Yes.

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Another highlight of recent highlight was the publication of our phase two clinical data that's on slide seven.

I expect here, we know the results.

The publicity emerge in the European Journal cancer, and the conclusion is highlighted here but.

Very especially combination, but you know significantly from both the overall survival and progression free survival, India entire patient population. This was irrespective of disparaging tentative expression.

And as mentioned in your introduction to the overall survival result in this empty and this I think people Appalachian Gill.

Course population is to our knowledge the strongest any large trial in this indication to date.

That's the second line pancreatic the phase three study on the next slide slide eight re elaborate on the other areas based trials the traffic up too is the phase two in triple negative breast cancer. This trial started enrollment in June 2019, no.

Enrolling patients in close to 20 sites in the for participating countries in Europe, Spain, Belgium, and we tend to UK.

The enrollment target is about 64 patients.

With an objective response.

Primary endpoint and we expect trial results in 2021.

Difficult to say exactly when the trial is slower than expected Btwenty one we.

We expect.

The results.

Yeah.

Done the recent phase one.

I guess.

Well.

Where we are we're not we but where every a space will be tested in combination with full freedom Nox is driven by the Georgetown.

Lombardi comprehensive cancer Center was the sponsor the update there I indeed.

Given the clearance to start the trial 90 based on our on our fight overseas.

And we now expect enrollment of the first patient second half could even be.

Earlier.

Oh, yes.

As a study would 12 to 18 patients to be angle.

Combination with a full sure enough to prepare the ground 40 later.

Face to face to treat study.

In first line the competition, which will finish on one hand gemabraxine on the owner.

And then there is the phase two honesty.

No I SP. This is snow. This study is that he was originally 30 patients was expanded to 50 patients. We're now they are now close to full enrollment and in the trial.

And then what is interesting here is that industrial we are.

They are the Ria space this being evaluated as an option to treat patients we developed allergy to the standard speculated asparaginase.

And we expect that.

Should be able to give an interim update by these first half of this year.

As we will heavily receive an interim update and that final data should become available by the end of this year.

So this the update on the clinical programs.

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On the next slides slide eight it's about the manufacturing US you know in order to be able to supply to probably 40 clinical trials, but also anticipating potential future commercial needs we.

There's a lot of work.

Only spending to manufacturing capacities.

Quite a quite an achievement to be able to its why we are doing all this is going to file sort of doubling the capacity in the new even at a second team so more than doubled.

And in Princeton, we built this brand new facility or can you speak wouldn't this brand new facility.

Which.

30000 square feet facility, where we have 60 field, which we now have for used for the use adequate for the ongoing trials.

All this.

Every a space then moving to the preclinical programs on slide 10.

So it's important that you can imagine that given this focus on that on the clinic the there.

Yes attention to the preclinical has sort of diminished a bit but still we are.

Remaining active.

The the loop leveraging.

Many actively.

Working on leveraging to every gifts platform towards new indications, a new product candidates.

And also partnership opportunities.

Hi, Chris the teams are working on three buckets. One is looking for combination still this is a real space, but I'm just looking for.

Which water treatment modalities could be synergistic with area space, we already know under combinations with chemotherapy for done all the fourth but there might be or the treatment modalities there.

This is if you.

Looking for Boulder.

Indications.

Stronger results with the product.

Dymatize todays program.

We have you know very nice data in different indications. There also combination data for example, with checkpoint inhibitors.

In the current.

Financing climate, let's say, we were focusing obviously on the older programs. What we currently see programs that we are advancing dymatize. This program to be able to bring into the clinic. Once we will have more financial resources to do so.

In the third pockets is partnering so you know in June we entered into an an agreement with Weve Biotechnologies Ron your motivation.

We are continuously looking for older partnership opportunities and in particular, the metabolic diseases. The rare diseases activities. We have if you have apartment.

And then finally to gulbrandsen topics I want to touch upon the first on you may see any Presley is the announcement that Alexander Alexander share or Chief Scientific Officer, we'll leave it takes to pursue another opportunity will be by the end of April.

He has done tremendous work on focusing to activities of the of the of the R&D team to preclinical team.

This this work will now be further contribute under the leadership of Costless, along with our director of R&D operations.

With no sorted through out there.

R&D activities.

So we think occasion here to tank Alexander for for his contributions and wishing him all the best for his future endeavors.

And then the older governance topic is the appointment of New Board member Doctor that on the role that you see wouldn't know deep in the board put a little frame, Iran. Melanie.

So.

If it's an appointment by the board that happened last week at the board meeting its a.

Quotation, which is sort of a preliminary appointment you still final ratification by the shoulder.

At the next Gen meeting, which is in June.

So dr. only really brings a strong experience in pharmaceuticals.

Close to 20 years, most of it Novartis 14 years, but which eight years U.S. excuse.

Bob.

In the field or medical affairs drug development safety.

And a lot of it in oncology. She is currently the CEO bigger therapeutics, a private oncology in dermatology focused company in the Basel, Switzerland.

So this concludes the company update.

No I like to hand, the call over two to every to guide you through our financial results for the full year doesn't thank you and you also summarized the upcoming milestones for the next 12 months.

Eric.

On the artist. Thank you. Thank you Jill and good morning, everyone bought Orthos.

We'll now on slide number 12, other slide deck with a financial highlights for the full years 2090.

And we're starting with a summary of or PML inflammation as you can see the net loss for the full year Tonight in was 62.7 million Euro.

It's about 24.4 million over the previous years for Tonight Treaty 18, plus 64 cents.

The increase in net loss is made of a 20 million increased 24 20.4 million increase.

Operating loss and the forming and decrease in financial income.

The 20.4 made an increase in operating loss.

Attributable to the.

Increase in preclinical and clinical development expenses, that's creating a name and that was mostly related.

For the company's phase three clinical trial in pancreatic cancer of the Tri be CA. One study also we have 2.5 million increase in GNS, you can see of which 2 million wasn't related to the expansion of the companies.

Manufacturing capacity.

You know, India, but also in the U.S.

And also in the same time, we had 0.8 billion euro increase in operating operating income.

That was primarily due to the.

1 million dollar.

Million euro upfront payments.

The company entered into the license agreements with squeeze.

Oh geez on every new platform.

So that was for the product for the PNM inflammation now a few words on cash.

I think the fee at the end of 2019.

The total cash position of 73.2 million Euro, which is approximately 82.2 billion U.S. dollar and that's compared with 174 million Euro on December 31 last years 20 2080.

Before and.

Total cash position of 81.9 million.

At the end of Q3.

Timber 30 to 90.

The decrease in cash position during the 12 months Oftwenty 19, 61.2 million degrees. It was the result of a net cash utilization of 63.1 million and that was comprised of 43.3 million euro or pricing activities and 19 point.

8 million for investing activities.

And in the same thing we had the appreciation of the U.S. dollar against the Euro and that's led to a one point banging the neural favorable currency exchange impact.

You, probably remind that we had the peak in capital expenditure disbursements in the first quarter of 20 banking.

And that was of course related to the extension the manufacturing facilities in the on them in the U.S. in Princeton and after that capitalization has gradually decrease during the remainder of the your four again total cash utilization for the.

For the year of 61.2 million.

So at this time, we believe that this cash position at the end of 2018, well be sufficient to fund or ongoing operations into the first quarter of 2021.

If I am now moving to the next slide number 13.

And that's a summary of all key milestones over the next 12 months and all of those of course already dimension in more detail by shielding the previous sites.

It was talking with them the interim update on the notional study that's the phase two in second line.

Well.

So again, we expect the interim update in the first half of these are 20.

But again this is an investigator sponsored trials investigator sponsored trial also of course, we're not putting control of the timely.

Then the next initiation of the phase one.

I see the phase one study with a response in first I think really cancer in which we could expect the for stations in the second half of this year 2020.

Obviously, the most important my sense of the year will be the interim analysis in Tribeca one on the phase three study in second line pancreatic cancer.

Again this isn't a nice is for superiority I feel it's already expired, we don't have to possible outcomes either continue or the final analysis, which is expected in the first half of 20 2021, sorry first half of 2021.

And the other possible outcome is a stop for superiority.

Which ends with a significant improvement in overall survival.

I've explained this interim analysis is expected towards the end of Q3 this year, but.

The necessary caveat that.

We don't have full clarity on the concept potential impact of the 19 situation.

Next is the full results of the no study in a though so entering interim results.

Earlier, this year and the final.

The final results towards the end of this year again, and I guess, the silicon motion control on the timeline here and finally, the phase one study another I see in first line.

He cancer in which we are expecting couldn't results hopefully by the end of bigger.

So that's the that's the main expected milestones for the next 12 months and with that I would like to.

Thank you all for your attention and will allow we'll now open the call for any questions. You may have just as a kind remains very kind of course question trench if you prefer to do so.

Of course, we can.

Answer either in French and English Jewish.

Operator over to you. Thank you.

As a reminder to ask a question really needs a press Star then one on your telephone.

Withdraw your question please press the pound.

Please standby, we compile the culinary Ross.

Our first question comes from the line of.

With Cowen and company. Your line is now open.

Hello, Good morning, good afternoon, appearing Europe.

Five already.

Hi, Bob.

My first question is on track back a one I'm just curious how does patient enrollment to date compare to the phase two trial.

Is that something that you're even able to compare at this time.

Mmm do you want to answer this question.

Yes.

Hi, good morning, good afternoon.

Good morning actually.

There.

Yeah.

We have different restrictions for this trial, it's you know it Oh.

Accelerated and gone retreat and so far what has been seen week one week since the start of the trial that the restrictions the action in the one means is meeting the projections for to try to.

Well, there's took a piece to try and appears to try and was a generic was conducted in Europe in France. Initially it had I mean can be a lag if there's an environment and then you start to actually it's it's very hard to compare in the joining me in the two studies because why do is one one country.

One nation.

There is a global energy.

Sorry, I didn't know what baseline characteristics of the patients so far and try back why are the phase two trial.

Eight oh.

Boy so far it is done so far its today.

Good luck three stakes in just the car one.

Very similar to the same station characteristics in into phase two trials, we have stayed in Milan inclusion exclusion criteria and we approved every single patient coming to the Giants. So that's the plan and that's what we are implementing and this is teach right.

My last question on me.

These two I see in second line AOL, which we expect results by year end. So if the study is positive what does the commercial implication or regulatory application. What are you going to do with a positive data.

Hi, Scott.

I'm sorry.

No no no I think it's.

It's a 50 patient study in an indication where there is this.

Unmet needs.

It's patients allergic to do.

Turning to spark.

Given the complexity Sharon or release.

We believe there isn't an unmet needs where this product good feel a dish, but obviously this will require further first of all.

The data and and also.

Dialogue with the agencies, whether indeed, there could be a path forward.

Based on these days.

Demand sort of go ahead, if you want.

Peter the this.

No dishes that that's what I would fit well into the don't you want anyone I would like to add that.

Because pieces study is currently conducted in instead for them.

Not excited.

First the investigator just energy is extremely.

Interstate into.

She is they really like the treatment. It continued to compare to squeeze every news and that is exactly why do you have asked us to increase this budget from a 30 to 50 patients so and they believed entities to unmet medical need for future consider.

He said.

Great. Thanks, very much picking my question.

Thank you.

Thank you our next question.

Oh, I believe Gardiner with Jefferies. Your line is now.

Oh, Hi, I've got a couple of question if I could maybe.

Firstly.

I think he said on the love all that you.

I will all of the Spike you plan type in the U.S. by the end at the close core classic in Egypt confirm how many sites you have opened in the U.S.

But you intend to question on Allied.

And then secondly, just coming back to cope with 19.

I appreciate that there's lots of uncertainty here, but in terms of some of the challenge is that you're potentially spacing do you think these are more from.

Patient not being willing to come to hospitals or do you think there's any risk that you won't be able to secure enough lug.

Or is there he could have risk so the patient follow up so any sort of detail that you can give that would be helpful. Thank you.

You might think bush's for for you.

Absolutely. Thank you.

Good morning cheaper.

You know regarding the first question on the U.S. activation, we are well.

We keep interest I actually think initiate and we're activating.

Sites in the U.S., we expect to.

It to complete or the site activation.

It's just a nickel.

Towards the end of March maybe maybe the first couple of weeks and it's been.

Additionally, the.

She remember we had to US because you are two months ago and Judy Brian.

She has a lot of interest from additional sites in the U.S.. We are also going through.

Additional sites.

Selection and an exhibition decides I think that's nice to to get as many sites in United States do have experienced some exposure to after treatment with upsize.

So overall, we are we are generally on targets as we have the guy that deluxe.

On the calling 19.

We are monitoring the situation on every single front and if I can just somebody like that on on a few buckets that that the first our kids is the patients as you mentioned.

The second bucket is the first thing they're not the seismic and of course, if they are smell didn't understand fixed under supply.

Additions so far we have not seen this has just started much and gets cleared in Italy and interest affect other European countries, we have not seen an.

In terms of experience being able to go to their respective sites I notice you think.

Then when do you have not seen in stock and goes on.

In the hospital.

Gee team personnel and of course, each it should start to your each site I appreciate instigators investigators and surgical or do you need to it's it's a whole number of personnel most unit in fact, even though we know about attorneys.

One size fits but im just to get too high.

Has been hit by school there so that has had an impact on.

It does have the logistics again, so far we have been even as you mentioned early to continue our supply to two different countries, both in Europe as well as indeed.

And I can mention one I talk example, here we have one site.

That has been he bayko big we have actually pushed us one of them has been shipped I called that.

Hi.

Patients.

It undermines a week ago Undine ideally, we were stores that dealership by the virus.

The being an issue interestingly enough. This very same site I as it's created another patient yesterday. So you can see if that's the sites are trying to do their best choice.

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Thats, where it for these patients from our inch we don't have an impact so far we have very closely we've got it goes as well as was the French blood Bank. We don't have any impact in terms of the sourcing of Dirty shows an hour labs, both in New York manufacturing sites, both in New York as what I hear.

In person our.

Operating.

I.

Providing their demands on Oh, oh, especially to decide that the inside the potential impact in our own the Seattle, we think the monitors to.

Look at the de diversify their data so that is the potential impact because again the trust restrictions. So it just not it's a rate limiting further did appealing but it is not.

Necessarily for patient enrollment attrition for the up.

I hope this answers your question.

That's great. Thank you.

Thank you.

Reminder, if you will like to ask your question. Please.

Please press Star then one on your telephone.

And we currently have no further.

Q.

Okay Dan.

And I. Thank you all four for your attention for your questions. We will keep you posted particularly in this special.

Specialties.

But indeed.

We know.

Things at all we continue to work on providing the progress on the trial as Stuart.

So I have.

Good day.

Good afternoon and.

Speak soon.

Thank you.

Ladies and gentlemen, this concludes todays oh. Thank you for participating you may now disconnect.

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